Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure

• Status: Withdrawn
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scripps Health
• Treatments: Metolazone

Criteria

Inclusion Criteria:

• Subject is 18 years of age at time of enrollment.

• Admitted with acute decompensated heart failure based on history, physical exam, and laboratory parameters, must include both:

1. At least 1 symptom of either dyspnea, orthopnea, or edema.

2. At least 1 sign of rales on auscultation, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography.

• Be willing to comply with protocol-specified instructions

• Able to understand and grant informed consent.

Exclusion Criteria:

• Inability to give informed consent.

• Systolic BP < 90 mmHg

• Creatinine clearance less than 20ml/min or creatinine greater than 2.5mg/dl.

• Serum Sodium less than 128meq/L, potassium levels less than 3.5meq/L

• Known adverse reaction to metolazone

• Inability to take oral medications

• Severe Aortic Stenosis (AVA < 0.8cm³)

• History of Hypertrophic Obstructive Cardiomyopathy.

• Metastatic Carcinoma

• Severe Chronic Obstructive Pulmonary Disease (COPD), FEV < 1L

• Severe dyspnea requiring prolonged CPAP or intubation

• Moderate/Severe Dementia